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Inova Diagnostics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
138
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K243979Aptiva APS IgA ReagentFebruary 6, 2026
K223093Aptiva APS IgG Reagent; Aptiva APS IgM ReagentDecember 17, 2024
K213403Aptiva CTD Essential ReagentSeptember 29, 2023
K200230Aptiva Celiac Disease IgG ReagentAugust 26, 2021
K193604Aptiva Celiac Disease IgA ReagentJune 16, 2021
K192916NOVA Lite DAPI dsDNA Crithidia luciliae KitDecember 11, 2020
K190088QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA ReagentsApril 17, 2019
K180971QUANTA Flash Calprotectin and Fecal Extraction DeviceOctober 16, 2018
K180975QUANTA Flash HMGCR ReagentsJune 25, 2018
K170993QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash CalprotectinDecember 22, 2017
K163538QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 ControlsSeptember 6, 2017
K163525QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) ControlsSeptember 5, 2017
K161258NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin KitFebruary 3, 2017
K152635QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 ControlsJune 1, 2016
K152013QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA ControlsApril 11, 2016
K151429QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 CiontrolsFebruary 12, 2016
K152875QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1December 21, 2015
K153150AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000November 24, 2015
K143754QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3September 21, 2015
DEN140039NOVA View Automated Fluorescense MicroscopeApril 9, 2015